Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01280305
Status:
UNKNOWN
Last Update Posted:
2011-01-20
First Post:
2011-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020849', 'term': 'Raloxifene Hydrochloride'}], 'ancestors': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-19', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-01-19', 'lastUpdatePostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PANSS total score at the end of the trial.', 'timeFrame': '3 times', 'description': 'PANSS will be assesed at weeks 5, 8 and end of study.'}], 'secondaryOutcomes': [{'measure': 'PANSS,CGI-S, CGI-I, BACS and rates of drop outs before the end of the trial.', 'timeFrame': 'PANSS 3 times, CGI-S and CGI-I 5 times and BACS 2 times', 'description': 'PANSS will be assessed at week 5, 8, and end of study; CGI-S, CGI-I, will be assessed at week 2, 5, 8, 12, and end of study; BACS will be assessed at week 8 and end of study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'schizoaffective disorder'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '28541645', 'type': 'DERIVED', 'citation': 'Weiser M, Levi L, Burshtein S, Hagin M, Matei VP, Podea D, Miclutia I, Tiugan A, Pacala B, Grecu IG, Noy A, Zamora D, Davis JM. Raloxifene Plus Antipsychotics Versus Placebo Plus Antipsychotics in Severely Ill Decompensated Postmenopausal Women With Schizophrenia or Schizoaffective Disorder: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e758-e765. doi: 10.4088/JCP.15m10498.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.', 'detailedDescription': 'Epidemiological evidence shows a potentially protective role for estrogen in women with schizophrenia. The onset of schizophrenia is later in woman than in men, with generally a less severe course until after the menopause, when for many women, reductions in estrogen levels appear to trigger an exacerbation or illness (Hafner 2003). ERα (Estrogen receptor alpha) expression is known to be reduced in schizophrenia (Wong, Woon et al. 2010). Raloxifene is a selective estrogen receptor modulator that acts as an estrogen antagonist in breast tissue and may have agonistic actions in the brain. Several studies (Kulkarni, Riedel et al. 2001; Chua, de Izquierdo et al. 2005; Kulkarni, Gurvich et al. 2010) indicate that treatment with estrogen and raloxifene improves symptoms in females with schizophrenia, and recently they showed an improvement in PANSS score in post menopausal women with schizophrenia receiving 60-120mg/d of raloxifene compared to placebo'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Post menopausal females: Post menopausal defined as: Women 45 years of age and older with no vaginal bleeding for at least 2 years prior to randomization, and both serum estradiol \\<73 pmol/L (20 pg/mL) and FSH \\>30 IU/L (30 mIU/mL).\n2. 45-65 years old\n3. Willing and able to provide informed consent, after the nature of the study has been fully explained.\n4. Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months.\n5. Symptoms: 4 (moderate) or above on CGI-S and 4 (moderate) score or above on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution, and/or a total PANSS negative symptoms score of 18.\n6. Must be on any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to insure that the dose is required and, if possible, will be stabilized on a lower dose prior to study entry.\n7. Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission.\n\nExclusion Criteria:\n\n1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions\n2. Women of child bearing potential.\n3. Women who have amenorrhea due to causes other than natural or surgical menopause i.e. eating disorders or exercise\n4. Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning.\n5. Patients treated with cholestyramine, warfarin or concurrent systemic estrogen therapy\n6. Likely allergy or sensitivity to raloxifene.\n7. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.\n8. Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.\n9. Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.\n10. Patients with hypercoaguable conditions or risk of venous thrombosis.'}, 'identificationModule': {'nctId': 'NCT01280305', 'acronym': 'RAL-S-01', 'briefTitle': 'Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'A Randomized Trial Administering Raloxifene vs Placebo as add-on to Antipsychotics in Post Menopausal Patients With Schizophrenia or Schizoaffective Disorder', 'orgStudyIdInfo': {'id': 'SHEBA-10-8287-MW-SHEBA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'raloxifene', 'interventionNames': ['Drug: raloxifene']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'raloxifene', 'type': 'DRUG', 'description': 'raloxifene 60 mg bid', 'armGroupLabels': ['raloxifene']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo bid', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'contacts': [{'name': 'Mark Weiser, MD', 'role': 'CONTACT', 'email': 'mweiser@netvision.net.il', 'phone': '972-52-666-6575'}, {'name': 'Mark Weiser, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Arad', 'country': 'Romania', 'contacts': [{'name': 'Delia Podea, MD', 'role': 'CONTACT', 'email': 'deliapodea@gmail.com', 'phone': '0722 583 757'}, {'name': 'Delia Podea, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica de Psihiatrie, Arad', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'city': 'Botoșani', 'country': 'Romania', 'facility': 'Spitalul de Psihiatrie Botosani', 'geoPoint': {'lat': 47.75, 'lon': 26.66667}}, {'city': 'Bucharest', 'country': 'Romania', 'contacts': [{'name': 'Dan Prelipceanu, MD', 'role': 'CONTACT', 'email': 'prelipceanudan@yahoo.com', 'phone': '0722 300 227'}, {'name': 'Dan Prelipceanu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'contacts': [{'name': 'Gabriela Marian, MD', 'role': 'CONTACT', 'email': 'gabi.marian@yahoo.com', 'phone': '0723 569 620'}, {'name': 'Gabriela Marian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'contacts': [{'name': 'Maria Ladea, MD', 'role': 'CONTACT', 'email': 'marialadea@gmail.com', 'phone': '0724 371 042'}, {'name': 'Maria Ladea, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'contacts': [{'name': 'Dorina-Valerica Sima, MD', 'role': 'CONTACT', 'email': 'dorinasima@yahoo.com', 'phone': '0723 859 570'}, {'name': 'Dorina-Valerica Sima, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'contacts': [{'name': 'Maria-Silvia Trandafir, MD', 'role': 'CONTACT', 'email': 'silviatrandafir2004@yahoo.com', 'phone': '0724 275 572'}, {'name': 'Maria-Silvia Trandafir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'contacts': [{'name': 'Ana-Liana Giurgiuca, MD', 'role': 'CONTACT', 'email': 'giurgiuca_liana@yahoo.com', 'phone': '0722 378 967'}, {'name': 'Ana-Liana Giurgiuca, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'contacts': [{'name': 'Valentin Matei, MD', 'role': 'CONTACT', 'email': 'petcu_camelia@yahoo.com', 'phone': '0723 640 918'}, {'name': 'Valentin Matei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'contacts': [{'name': 'Mircea-Alexandru Birt, MD', 'role': 'CONTACT', 'email': 'mirceabirt@yahoo.com', 'phone': '0721 012 220'}, {'name': 'Mircea-Alexandru Birt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sp. Jud. "Prof. Dr.O. Fodor"', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'contacts': [{'name': 'Ioana-Valentina Miclutia, MD', 'role': 'CONTACT', 'email': 'ioanamiclu@yahoo.com', 'phone': '0722 796 067'}, {'name': 'Ioana-Valentina Miclutia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic Judetean de Urgenta Cluj', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Iași', 'country': 'Romania', 'contacts': [{'name': 'Serban Turliuc, MD', 'role': 'CONTACT', 'email': 'serban_turliuc@yahoo.com', 'phone': '0745 203 002'}, {'name': 'Serban Turliuc, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Psihiatrie Socola, Iasi', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}], 'centralContacts': [{'name': 'Mark Weiser, MD', 'role': 'CONTACT', 'email': 'mweiser@netvision.net.il', 'phone': '972-52-666-6575'}], 'overallOfficials': [{'name': 'Mark Weiser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Mark Weiser MD', 'oldOrganization': 'Sheba Medical Center'}}}}